A Standardized Validation Framework for Clinically Actionable Healthcare Machine Learning with Knee Osteoarthritis Grading as a Case Study

Abstract

Background: High in-domain accuracy in healthcare machine learning (ML) models does not guarantee reliable clinical performance, especially when training and validation protocols are insufficiently robust. This paper presents a standardized framework for training and validating ML models intended for classifying medical conditions, emphasizing the need for clinically relevant evaluation metrics and external validation. Methods: We apply this framework to a case study in knee osteoarthritis grading, demonstrating how overfitting, data leakage, and inadequate validation can lead to deceptively high accuracy that fails to translate into clinical reliability. In addition to conventional metrics, we introduce composite clinical measures that better capture real-world utility. Results: Our findings show that models with strong in-domain performance may underperform on external datasets, and that composite metrics provide a more nuanced assessment of clinical applicability. Conclusions: Standardized training and validation protocols, together with clinically oriented evaluation, are essential for developing ML models that are both statistically robust and clinically reliable across a range of medical classification tasks.

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